Due to manufacturing issues, a formulation of the bladder cancer treatment bacillus Calmette-GuÃ©rin is currently unavailable from one manufacturer.
Due to manufacturing issues, a formulation of the bladder cancer treatment bacillus Calmette-Guérin is currently unavailable from one manufacturer.
TheraCys, which is indicated for the treatment of nonmuscle-invasive bladder cancer, is forecast to remain unavailable until late 2013, according to manufacturer Sanofi Pasteur, Ltd.
The company has decided to temporarily suspend manufacturing in order to renovate its facility to improve environmental quality management within the production building, Sanofi Pasteur said in a statement. An April 2012 FDA inspection of the Sanofi facility located in Toronto noted "numerous deviations relating to the isolation of mold within the aseptic processing areas," according to the FDA.
The FDA said it has been working with and continues to work with Organon Teknika, Corp. LLC, a subsidiary of Merck & Co, Inc., to increase the production of TICE BCG, the other U.S. licensed source of BCG, to assist with meeting critical patient needs during this shortage.
To help minimize the disruption in patient care, the FDA said it encourages physicians, distributors, and others not to stockpile BCG. In the meantime, because of increased demand for TICE BCG, customers may experience shortages as the demand for this product exceeds the available inventory. It is hoped that increased production of TICE BCG will help to minimize the impact of the overall BCG shortage, the agency said.